Key result
Two Epaxal Junior doses maintain protective anti-HAV antibodies in 100% of children at 5.5 years.
Why the study?
The long-term immunogenicity of the pediatric dose of the virosomal hepatitis A vaccine Epaxal Junior in children was investigated to assess antibody persistence.
Does the pediatric formulation of an aluminum-free virosomal hepatitis A vaccine provide long-term immunogenicity in children?
Cohort (n=271)
Does the pediatric formulation of an aluminum-free virosomal hepatitis A vaccine provide long-term immunogenicity in children?
Vaccination of children with two doses of the pediatric virosomal hepatitis A vaccine confers protective antibodies for at least 5.5 years.
Sustained protection to 5.5 years supports pediatric Epaxal Junior use; cohort data leave open exact duration and prospective confirmation.
BACKGROUND: The pediatric dose of the virosomal hepatitis A vaccine Epaxal, Epaxal Junior, is safe and immunogenic in children from 1 to 17 years of age. The present study investigated the long-term immunogenicity of Epaxal Junior. The standard doses of Epaxal and aluminum-adsorbed hepatitis A vaccine (Havrix Junior) were used as comparators. METHODS: A total of 271 children who had completed a 0/6-month immunization schedule (priming and booster dose) participated in this follow-up study. Anti-hepatitis A virus (HAV) antibody levels were measured using a microparticle enzyme immunoassay (HAVAB 2.0 Quantitative; Abbott Diagnostics, Wiesbaden, Germany) starting at 18 months following the second dose, and then yearly until 66 months (ie, 5.5 years) after the second dose. RESULTS: All subjects tested at Month 66 still had protective anti-HAV antibodies (≥10 mIU/mL). Antibody titers were generally lower in subjects 1-7 years old than in subjects 8-17 years old and higher in females 11-17 years old than in males 11-17 years old. In addition, an age-dependent decay was observed, that is, antibody decreased more rapidly in younger than in older children. CONCLUSIONS: Vaccination of children with two doses of Epaxal Junior confers a real-time protection of at least 5.5 years. This protection is estimated to last approximately 25 years. Younger children showed lower antibody titers and a faster antibody decline than older children. Additional follow-up studies are needed beyond 5.5 years to further assess the long-term immunogenicity of Epaxal Junior.
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Herck et al. (2014) conducted a cohort in Hepatitis A (n=271). Epaxal Junior (pediatric formulation of an aluminum-free virosomal hepatitis A vaccine) vs. Standard doses of Epaxal and Havrix Junior was evaluated on Protective anti-HAV antibodies (≥10 mIU/mL) at 66 months. Vaccination with two doses of Epaxal Junior resulted in 100% of children maintaining protective anti-HAV antibodies (≥10 mIU/mL) at 5.5 years of follow-up.
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